Desvenlafaxine Pregnancy and Breastfeeding Warnings

Desvenlafaxine Pregnancy Warnings

Animal studies have revealed no teratogenic effects. There are no adequate and well-controlled studies in pregnant women. Additionally, neonates exposed to SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester required prolonged hospitalization, respiratory support, and tube feeding. Other reported clinical findings have included: respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. This clinical picture is consistent with either a direct toxic effect of SSRIs and SNRIs, a drug discontinuation syndrome, or a serotonin syndrome.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.
AU TGA pregnancy category: B2
US FDA pregnancy category: C
Comments: Women who discontinued antidepressant use during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant use.

Desvenlafaxine Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comments: The effects in the nursing infant are unknown.

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